Leaflet: information for the user

Iruxol Neo ointment

Read this leaflet carefully before you start using the medicine

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you and should not be given to others, even if they have the same symptoms, as it may harm them.
• If you consider that any of the side effects you are experiencing are serious or if you notice any side effects not mentioned in this leaflet, inform your doctor or pharmacist.

1. What Iruxol Neo is and for what it is used

2. Before using Iruxol Neo

3. How to use Iruxol Neo

4. Possible side effects

5. Storage of Iruxol Neo

6. Additional information

The active principles are proteolytic enzymes that act on components of ulcers and skin wounds, and an aminoglycoside antibiotic. It is indicated in adults, for the debridement (cleaning and removal) of necrotic (dead) tissues in small-sized skin ulcers of various origins, and reduction of the amount of superficial bacteria.

No use Iruxol Neo

-If you are allergic (hypersensitive) to the active ingredients, other aminoglycoside antibiotics, or any of the other components of this medication.

Be especially careful with Iruxol Neo

-Iruxol Neo should not be used on extensive areas, as neomycin could be absorbed through the skin and cause adverse effects in other parts of the body. This is more likely if you have kidney disease or are being treated with another aminoglycoside antibiotic by mouth or other routes (e.g. amikacin, tobramycin, or gentamicin).

-If you notice an infection in the wound or have developed overinfections by resistant microorganisms, consult your doctor, who will apply the appropriate treatment. There are antibiotics that cannot be used with this medication in the same area (see sectionUse of other medications).

-If you use the cream with some soaps or antiseptics, it may eliminate the effect of this medication (see sectionUse of other medications).

-You should avoid contact of the cream with the eyes or mucous membranes (e.g. the genital area).

-If you are weakened, caution is required and you should consult your doctor for the risk of spreading an infection.

-This medication should not be used in children, as its safety and efficacy have not been established in them.

Use of other medications

Inform your doctor or pharmacist if you are using or have recently used other medications, including those obtained without a prescription.

-Aminoglycoside antibiotics (e.g. amikacin, tobramycin, or gentamicina): If you are being treated with any of these antibiotics, by mouth or other routes, it may increase the risk of adverse reactions in other parts of the body.

-The following productsshould not be usedconcurrently with Iruxol Neo because they may reduce or suppress its activity:

-Topically applied antibiotics such as tyrothricin, gramicidin, and tetracyclines

-Detergents, soaps, acidic solutions, or antiseptics such as hexachlorophene or those containing heavy metals (e.g. mercuricromes).

-Other enzymatic preparations.

-Yes, the following products can be usedconcurrently with Iruxol Neo:

-Antibiotics such as neomycin, bacitracin, polymyxin B, and framycetin.

Pregnancy and lactation

Consult your doctor or pharmacist before using any medication.

To avoid any risk to the baby, do not use Iruxol Neo if you are pregnant or breastfeeding, unless your doctor advises you to do so, weighing the benefits against the potential risks.

Driving and operating machinery

No effects of Iruxol Neo on driving or operating machinery have been described.

Follow exactly the administration instructions for Iruxol Neo as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

Cutaneous use.

To pierce the sealed tube, press using the reverse of the cap. The normal dose is:

Adults

Apply a layer of ointment of approximately 2 mm in thickness, once a day, directly on the area to be treated, lightly moistened with hydrogel or physiological serum. It can also be applied on a sterile gauze or dressing placed over the wound. In some cases, it may be necessary to apply the ointment twice a day.

Strict aseptic conditions must be maintained. Before each application, the wound should be gently cleaned with a gauze soaked in physiological serum or another compatible cleaning solution to remove necrotic tissue.

Generally, the medication should not be used for more than a week, unless the doctor decides to prolong it further. If no reduction in necrotic tissue is observed after 14 days from the start of treatment, inform the doctor, who will interrupt and replace it with another.

Use in children

The safety and efficacy of Iruxol Neo in children have not been established, and therefore it should not be used in this age group.

If you use more Iruxol Neo than you should

If you use more Iruxol Neo than recommended, in large areas of skin erosion (e.g. in ulcers) or for prolonged periods, neomycin could absorb in sufficient quantities to produce adverse effects such as hearing loss, renal damage, and muscle relaxation (neuromuscular blockade). Rarely, severe dermatitis has been reported due to local use of neomycin, one of the active ingredients of this medication. In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or visit a medical center, or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to use Iruxol Neo

Do not use more ointment to compensate for the missed doses. If you have forgotten a dose, apply it as soon as possible and continue with your regular schedule.

If you interrupt treatment with Iruxol Neo

Do not interrupt treatment before the indicated time by your doctor, or the desired results will not be obtained.

If you have any other doubts about the use of this product, ask your doctor or pharmacist.

Like all medications, Iruxol Neo may produce adverse effects, although not everyone will experience them.

The assessment of adverse effects is based on the following frequencies:

Very frequent: may affect more than 1 in 10 people.

Frequent: may affect between 1 and 10 in 100 people.

Adverse effects observed include pain, itching, irritation, inflammation, or redness of the skin, which usually do not require discontinuation of treatment.

Hypersensitivity reactions to neomycin are common, especially with prolonged use, including: inflammation, burning, rash, appearance of hives (urticaria); rarely, anaphylactic reactions (exaggerated allergic reaction) may occur.

For excessive use of the medication, see sectionUsing more Iruxol Neo than you should.

If you consider any of the adverse effects you are experiencing to be severe or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

Reporting Adverse Effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keep out of reach and sight of children.

Do not use Iruxol Neo after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 25°C.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medicines you no longer need.By doing so, you will help protect the environment.

Composition of Iruxol Neo Ointment

• The active principles are: Clostridiopeptidasa A (Collagenase) 0.6 U/g and Neomycin (as sulfate) 3.5 mg/g.
• The other components are: liquid paraffin and white vaseline.

Appearance of the product and contents of the package

Iruxol Neo is presented in the form of an ointment, white or slightly brown. Each package contains 15 or 30 g of ointment in an aluminum tube.

Holder of the marketing authorization

Smith & Nephew GmbH

Friesenweg 30, 22763 Hamburg, Germany.

Manufacturer

Nordmark Pharma GmbH

Pinnauallee 4, 25436 Uetersen, Germany.

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Local Representative

Smith & Nephew, S.A.U

Fructuós Gelabert, 2-4

08970 Sant Joan Despí Barcelona, Spain

Tel: +34 93 373 7301

Fax: +34 93 373 7453

This prospectus was approved in April 2018.

The detailed and updated information about this medication is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.es/